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510(k) K770595

SUTURE REMOVAL SET by Abco Dealers, Inc. — Product Code JOK

K770595 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "SUTURE REMOVAL SET". The FDA issued a decision of Substantially Equivalent on May 23, 1977. The device falls under product code JOK (Scissors, Medical, Disposable), a Class I device regulated under 21 CFR 880.6820. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1977
Date Received
March 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, Medical, Disposable
Device Class
Class I
Regulation Number
880.6820
Review Panel
HO
Submission Type

Other clearances by Abco Dealers, Inc.

  • K905025 — DIGITAL THERMOMETER KITS (February 7, 1991)
  • K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (July 12, 1988)
  • K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS (April 21, 1988)
  • K880894 — ALLERGIST SYRINGES (March 31, 1988)
  • K872875 — STRETCH GAUZE BANDAGES (September 4, 1987)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)
  • K872797 — NON-SKID SHOE COVERS (August 4, 1987)
  • K871465 — THERMOMETER SHEATHS (May 11, 1987)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)

Other clearances for product code JOK

  • K855131 — SUTURE REMOVAL KIT (January 13, 1986)
  • K843075 — UTILITY SCISSORS DISPOSABLE ITEMS (September 5, 1984)
  • K812555 — DISPOSABLE SUTURE REMOVAL SCISSORS (November 16, 1981)
  • K770481 — SHEAR, PLASTIC HANDLE UTILITY S-475-7 (April 29, 1977)
  • K770163 — SUTURE CUTTER (March 30, 1977)
  • K761192 — DRESSING CHANGE KIT (February 28, 1977)

FDA data resources